System and method for real time management of a drug regimen

ABSTRACT

A system for managing a prescribed drug regimen for a user, the system including at least one electronic device (Pod) for interactive communication with at least one user, a Pod server coupled via a communication link to each Pod, said Pod server including an analysis unit, the analysis unit including a database of drug characteristics, and a processor for comparing sensed characteristics of a drug in one of the Pods with characteristics in the drug characteristics database, so as to identify the drug, and to provide to the Pod an indication of compatibility of the drug with the drug regimen.

RELATED APPLICATIONS

This application claims the benefit of Provisional Applications Nos.60/798,278 and 60/798,279, both filed May 6, 2006.

FIELD OF THE INVENTION

The present invention pertains to a system and method for managingpatient care associated with a prescribed drug regimen.

BACKGROUND OF THE INVENTION

Drugs are effective in treating a wide range of diseases and medicalconditions. They are designed to be consumed according to a definedprotocol, which includes dosing and timing. Demand for prescriptiondrugs is growing at a rate that exceeds the capacity and numbers oflicensed pharmacists. Currently more than 200 million prescriptions arefilled in the US alone every week. The number of prescriptions filledbetween 2000 and 2005 increased roughly by 41%, while the number ofretail pharmacists increased roughly by 4.5%.

However, there are a few major problems associated with prescribed andnon prescribed drugs, which create a safety risk or reduced efficacy:

-   -   1. Drug-drug interactions which occur when actually consuming        the drugs    -   2. Medication errors made by physicians    -   3. Non compliance and non-adherence by patients    -   4. Vending errors by pharmacists    -   5. Drug counterfeit

Errors can be made in any stage of the drug cascade: manufacturing,prescribing, dispensing and consumption. They can occur at themanufacturing site, in hospitals, pharmacies, community clinics and athome. Two in-patient studies, one in adults and one in pediatrics, havefound that about half of medication errors occur at the stage of drugordering, and direct observation studies have indicated that many errorsalso occur at the administration stage.

The purpose of the invention described herein is to assist patients andpeople who consume medications to considerably reduce the riskassociated with these factors.

1. Drug-Drug Interactions:

All drugs affect multiple organs and many systems, and have differentmechanisms of absorption, distribution metabolism and elimination.However, many, if not most, individuals take more than one drug at atime. Once a drug is consumed, it may alter one or more of the mechanismof action of another drug causing a reduction of efficacy or a toxiceffect.

While clinicians are in general familiar with the concept of crossactivities of drugs, which are mentioned in the summary of productcharacteristics (SmPC) and prescribing information (PI), in many casesthey are unaware of specific potential interactions while prescribing adrug for one of the following reasons: The clinician is prescribing thedrug only in rare cases, the drug is new on the market, the patient didnot disclose all drugs he/she is taking (or was not asked about them),personal habits are not disclosed (dietary, alcohol, smoking, etc.) orthe clinician or the pharmacist is not familiar with many of thepossible combinations of drug interactions

2. Medication Errors

Medication errors are errors in the processes of ordering, transcribing,dispensing, administering, or monitoring drugs, irrespective of theoutcome (i.e. injury to the patient).

3. Non-compliance and Non-adherence

Non-compliance and non-adherence errors are made by the patient. Theprincipal types of non-compliance errors are: missing a dose, incorrectdrug, incorrect frequency of administration, or completely stop takingthe drug

4. Vending Errors

This type of errors occurs when drugs are sold by a pharmacist to thepatient. Typically, these errors occur due to similar names or similarpackages of drugs. A high work load on pharmacists also contributes tothe error rate.

5. Drug Counterfeit

This is a growing issue where a look-alike drug, which may contain aninert or a different material, is sold on the market as if it were theoriginal drug. The danger here is that the patient will not get thebenefits of the proper drug, at all.

SUMMARY OF THE INVENTION

The present invention pertains to a system and method for managingpatient care associated with a drug regimen. The purpose of theinvention described herein is to assist patients and people who takemedications and other drugs to considerably reduce the risk associatedwith the above factors.

For purposes of the present invention, the term “drug” is used toinclude prescription drugs and non-prescription drugs (also known asOver the Counter (OTC) drugs), food supplements, vitamins and preventivedrugs.

The invention provides a system designed primarily for residential useby people who are on a drug regimen. The drug regimen includes alldrugs, prescribed and not prescribed, food supplements, vitamins, andthe like, taken by a person, including dosage and timing, and preferablyincludes an indication of allergies or sensitivities to any drugs orfood supplements to be used during drug analysis. The system aims ateliminating errors associated with taking drugs, alerting users topossible adverse drug interactions and reminding users to take theirdrugs, thereby improving compliance with the drug regimen.

The basic system design includes an electronic client terminal device (aPod) for interactive communication with a user, software and medicaldatabases, preferably running in a remote computer (server or PodServer), and communication links between the Pod and the Server.

Optional modules of the system include a client Web interface.Preferably, a drug to be identified before taking is placed in the Pod.The system performs processing on the remote server to determiningcompatibility of the drug with the user's drug regimen, and relaysresults of the analysis to the user. Preferably, based on the analysis,the Pod either releases the blocks to the user or blocks it. In thelatter case, the user may override the blocking function and may alsocommunicate with a remote service center, in one of several mannersincluding, among others, text and voice.

Several embodiments of suitable Pods, which are capable of beingassociated with one or more users, are described in detail and claimedin applicants' co-pending patent application entitled: Apparatus andMethod for Obtaining an Identification of Drugs for Enhanced Safety.

The remote computer server is capable of simultaneously interacting witha plurality of Pods and includes an analysis unit having databases withusers' drug-taking history, users' regimen, drug data, drug interactiondata, and communication hardware and software.

The communication links facilitate data, voice, and video communicationbetween a user and the server and, in one embodiment, between users andexpert consultants or a support center. Communication can be over theInternet, cellular networks, satellite links, or any other communicationtechnologies.

The Web interface allows users to enter their drug regimen into thesystem, view their medication taking history, and next dose information.

The Server is capable of communicating with a plurality of Pods.Preferably, the Pods are located at consumers' premises, or may beportable devices for carrying with the user. According to one preferredembodiment of the invention, the Pods are devices capable of capturingimages, and/or additional optical information or other characteristicsof the drugs, other optical elements embedded in drugs or imprinted onthe drugs themselves, or on their packaging.

Preferably, the server contains capabilities allowing it to activelyalert and send further information to a user or users by using the Podto display the alert. According to another preferred embodiment of theinvention, the Pod may contain additional communication capabilities andinput/output capabilities enabling the user to communicate with expertsby using voice or data, or enabling the Pod to display video informationcommunicated to it by the Pod Server.

According to one embodiment of the invention, the system utilizes Podsthat are able to capture images or other data regarding a drug that theuser is taking, and transmit the information to the Server. In apreferred embodiment, the Pod includes at least one camera, and alighting mechanism. This allows the Pod to capture images and then sendthem to the Pod server. In some other embodiments, processing takesplace in the Pods and they either send the processed results to the Podserver, or if they are not connected to a communication network at thatparticular moment, they store information of medications inside the Pod.That information may be communicated to a Pod server at a later time,when connected.

According to another embodiment of the invention, a Pod can be acellular telephone equipped with a camera and software that enables itto send images captured by the camera to the Server.

According to a preferred embodiment of the invention, a user has one Podand the Pod is associated with the user using identifiers, such as ahardware identification code or a telephone number. However, it shouldbe noted that more than a single Pod could be associated with a user andmore than one user can use a single Pod—for example, a family may use asingle Pod, as by providing different access codes or identificationmeans for each user. The terms “drug”, “medication” and “pill” will beused in this application interchangeably. So will Server and Pod server.

Thus, the invention described in this document is a comprehensive systemwhich:

-   -   Identifies each tablet pill or drug, at the final target point,        just before consumption,    -   Is applicable to all drugs, in any form or shape    -   Does not require any preparation or modification in the        production line or packaging of the drug    -   Does not require pharmacists' time, intervention or any        modification at the point of vending    -   Is easy to use    -   Evaluates in real time any patient sensitivities or possible        drug interactions in accordance with a patient's clinical        information    -   Communicates back with the patient and/or his/her care giver    -   Alerts a patient and/or care provider regarding any deviation        from the planned drug schedule    -   Enhances economics of drug use    -   Collects detailed information about the exact ways users take        drugs, together with exact identification of each drug taken.        Thus, this invention may assist drug safety authorities (such as        the FDA) in evaluating benefits and hazards of new drugs, after        the drug has been released for marketing—contributing to public        health and safety.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

The invention will now be described in greater detail with reference tothe preferred embodiments illustrated in the accompanying drawingswherein:

FIG. 1 depicts the overall design of a system in accordance with apreferred embodiment of the invention.

FIG. 2 depicts the basic structure of a Pod according a preferredembodiment.

FIG. 3 is a simplified flowchart showing how a user initiates an accountand feeds data to the system of the invention.

FIG. 4 is a simplified flowchart showing how a user can use the systemof FIG. 1.

FIG. 5 is a sample front page of the web service according to apreferred embodiment.

FIG. 6 is a sample page showing user data that is updated in real-timein accordance with a more preferred embodiment of the invention.

FIG. 7 depicts a design of a system showing a Pod 701 connected by alink 706 to a personal computer (PC) 702, which is connected by acommunication network 703 to a Pod server 704, which PC is alsoconnected to a web server 705.

DETAILED DESCRIPTION OF THE INVENTION

The present invention pertains to a system and method for managingpatient care associated with a prescribed drug regimen. The systemincludes modules for performing identification of a drug before it istaken by a user, comparing it to known drugs, verifying whether the userhas a sensitivity to the drug or if an adverse drug interaction couldoccur, in accordance with the user's clinical information.

FIG. 1 illustrates a system architecture overview and several possibleimplementations of preferred embodiments of the invention. Pod 100establishes connection to a server via a data link. According to apreferred embodiment, Pod 100 is connected to a wireless network, forexample an IEEE 802.11n wireless IP network, and via a router 110 to abackbone broadband IP network 150. From the IP network 150, data isexchanged between Pod 100 and Pod Server 130. The data can be routedeither via public internet 151, or via a private network or a privatepeering arrangement 160.

Once turned on, Pod 100 searches for a network to join. When aconnection to the network is established, Pod 100 sends registrationinformation to Pod server 130 via the network. The Pod server may beidentified by a pre-set DNS name or pre-set global IP address, alreadystored within each Pod, or in any other suitable manner.

According to one embodiment of the invention, Pod 103 is located at theuser's home, and connected to Pod Server 130 via a home network by knowndata networking links, in a similar manner to that in which a commonPersonal Computer (PC) communicates with servers over the Internet.

According to one embodiment of the invention, a Pod 102 can use cellularIP communications capabilities and protocols, such as GPRS, to connectto Pod Server 130, and a Pod 104 can use a wide-area wireless broadbandnetwork, such as WiMAX, for connecting to the Pod server.

Pod Server 130 is connected to Internet 151 or to IP network 150 viabroadband links 161 or 160, respectively. In order to optimize thesolution for traffic originating from multiple Pods, or due togeographic constraints, multiple Pod Servers can be used. Optionally, aload balancer, a firewall and other known means (not shown), that areutilized by web sites to balance traffic and protect against hackers'attacks, that are used by Internet server centers, can be used tooptimize data flow to and from the Pods.

Thus, the present invention serves as a personal or domestic drugverification system that encompasses drug identification, communicationlinks, analysis, and warning system. One identification system,utilizing images of the drug, is described herein, although otheridentification systems, such as Infra-red or laser-based chemicalanalysis, and so forth, can alternatively be integrated into the system.

In one embodiment, the Pod includes a housing defining a drug path forreceiving a drug to be identified, one or more sensors in the housingfor sensing and recording selected characteristics of a drug in the drugpath, means for transferring the recorded characteristics to a Podserver for analysis, means for receiving analyzed data of the recordedcharacteristics, and a display for displaying the received data.According to one embodiment of the invention, the Pod server includes ananalysis module including a medical database storing selectedcharacteristics of as many drugs as possible, and a processor forcomparing the sensed characteristics of the drug to be identified withcharacteristics of the drugs in the database, so as to identify thedrug. The processor may also be enabled to provide an indication ofpotential drug interactions.

FIG. 2 illustrates a Pod 220 according to a preferred embodiment of theinvention. In this embodiment, the sensors include devices for capturingimages of the exterior of the drug so as to permit analysis of size,color, markings, etc. Pod 220 includes a housing 200, at least one, andpreferably a plurality of cameras 207, drug retaining elements, hereshown as a gating element 208 and an associated gating motor 209. Pod220 further includes a drug path 206 having at a first end a drug entryopening 203, and at a second end a drug exit 211, a power connector 205,an electronics and software module 204, a battery 210, and a display201. Module 204 may include discrete electronics, such as hard wiredcircuitry, or according to a preferred embodiment, a controllercontrolled by software, and can further include circuitry for powermanagement, control, etc. It is appreciated by those skilled in the artthat, according to preferred embodiments of the present invention,module 204 may include communication link capabilities provided byhardware, software or a combination of both. Such a communication linkcan be provided by a module which is completely or partially separatedfrom module 204.

The method of the present invention is substantially as follows. A userreceives a Pod having a unique identifier, and registers the Pod with anappropriate Pod server as belonging to that user. The drug regimen ofthe user, including prescription drugs, non-prescription drugs, foodsupplements, etc., is entered into the Pod and stored there. A number ofmethods are available for entry of the user's data regimen, examples ofwhich are described below. Any drug allergies or sensitivities of theuser may also be entered into the Pod. If desired, the Pod can alreadyperform a drug interaction analysis, to ensure that there are no adverseeffects from the combination of drugs in the proposed drug regimen. Ifthere are liable to be complications arising from the combination ofdrugs, an alert will be provided by the Pod for verification andfollow-up by the user or his or her caregiver.

When a user wants to take a drug, such as a pill, either because it isthe proper time to take the drug according to his prescribed regimen, orfor any other reason, he places the pill in the Pod for identification.Selected characteristics of the pill will be analyzed in the Pod and/orin the pod server, and compared with characteristics of known drugsstored in a drug database. When the drug has been identified and itscompatibility with the user's drug regimen has been determined, anotification is displayed for the user, who is also informed that he maytake the drug or should not take the drug, for various reasons.

As an option, the Pod may be placed near, or in conjunction with, a pilldispenser, for example, MD.2 Automatic Pill Dispenser available fromEpill, 70 Walnut Street, Wellesley, Mass. 02481, USA. Once a pill isdispensed by the Pill Dispenser, it is dispensed into the entry opening203 (this can be achieved either automatically by placing the Pod nextto the Pill Dispenser, or manually by the user). Then the process ofpill identification and the other tasks described herein take place asdescribed below.

According to one embodiment of the invention, the Pod provides areminder to the user, at the appropriate time, to take a certain drug.Upon receiving confirmation from the user that the drug has been taken,the Pod will update its reminder system accordingly.

This method will now be described in detail with regard to one preferredembodiment of the invention.

When the user plans to take a pill, the user introduces a drug to Pod220 through drug entry opening 203. Alternatively, Pod 220 may beconnected to a drug dispenser, which when triggered by the userdispenses a pill or pills into opening 203. The pill moves along thedrug path 206 to an analysis area. According to this embodiment, thepill is retained in the analysis area by gating element 208, which ispreferably a revolving gate formed of glass, or other transparentmaterial. Camera 207 takes a snapshot or several snapshots of the pillfrom one or more shooting angles. Camera 207 is shown in this embodimentas a single camera. However, preferably more than one camera may be usedto capture physical characteristics of the pill from all angles. Camera207 captures images of the pill through transparent gate element 208. Itwill be appreciated that camera 207 can comprise image sensors that aresensitive to the visible spectrum, for example color RGB(Red-Green-Blue) cameras which yield a color image. Alternatively,camera 207 can comprise a camera having image sensors, filters andlighting elements that produce images in the non-visible spectrum, suchas near-infra-red images, which are not visible to the human eye. Infrared imaging provides an analysis of the drug's coating composition,enabling identification of the drug and also detection of counterfeitdrugs.

The drug moves along the drug path 206 to an analysis area. In thisembodiment, the drug is retained in the analysis area by a gatingelement 208, which is preferably embodied as a revolving glass gate, ora gate of another transparent material. One or more cameras take asnapshot or snapshots of the pill from one or more angles. One camera207 is shown in this embodiment, but preferably there should be morethan one camera to ensure capturing all aspects of the pill. The camerascapture images of the pill through the glass gate to obtain images ofthe pill from aspects that may be obscured if the gate were made ofopaque material. It should be noted that the terms “camera” and “images”refer to cameras having image sensors that are sensitive to the visiblespectrum, as well as to cameras having image sensor, filters andlighting elements that produce images in the non-visible spectrum, suchas near-infra-red images, which are not visible to the human eye.Details of such cameras and lighting are provided in applicants'co-pending patent application entitled Apparatus and Method forObtaining an Identification of Drugs for Enhanced Safety.

A gating motor 209, or a linear actuator or any other suitable element,can revolve the gating element 208, to permit the pill to continue itspassage through the drug path 206 and get to the other end of the Pod atexit point 211. It will be appreciated that the specific activation ofthe gating mechanism will depend on the structure used and will be atechnical choice clear to the skilled technician.

In a preferred embodiment, all the electronics, which preferablyincludes a programmable microprocessor, motor driver, cameracontrollers, memory and communication software preferably are located inthe electronics and software module 204. In another embodiment of theinvention, these functions may be performed by a cellular telephonehandset that is coupled to the Pod via a cable. Power may be fed viapower connector 205. According to one embodiment of the invention, attimes when power is not available, battery 210 can provide power.

The Pod is connected to an IP or other wireless communication networkvia antenna 202 that may be internal to the Pod or telescoping outwards,as needed. According to one embodiment of the invention, a display 201provides feedback to the user. Such feed-back can be, for example, theidentification of the pill and additional information about thatparticular drug. This information can be transmitted to the Pod by PodServer 130 from FIG. 1. According to a preferred embodiment of theinvention, display 201 can be a touch-screen which enables user's inputfor set-up or for placing orders.

According to another preferred embodiment of the invention, a Pod may beconnected, preferably wirelessly, to other or additional externalsensors which measure a physical property of the user, such as a scalewhich measures person's weight, a blood pressure meter, a blood glucosemeter and the like. The exact type of external sensor may be determinedby the patient or by their care givers or service providers. Typically,the external sensor measures a physiological parameter that iscontrolled by the drug or drugs that patient is required to consume. Byautomatically reading physiological parameters at a time of consumptionof drugs, or potentially at other times as well, there is a linkagebetween the drug, exact time of consumption, dose, and other drugs takenby the patient, to an outcome—the change in the measured physiologicalparameter. This may have the advantage of providing a feed-back to thepatient, potentially encourage him or her to adhere and comply withtheir drug regimen, and provide to the physician a way of adjusting thedose or combination of drugs by looking at the outcomes. Preferably, thereadout of the external sensor or sensors is communicated back to thePod server, and may get displayed upon request of the patient or othersas described in this application.

According to another preferred embodiment of the invention, screen 201has a capability to display video. The video may be received from thePod Server as compressed video over IP protocol, for display on display201. The video can provide information about the use of drugs, alsoknown as informational video. The video can also contain footage of adrug expert or technical support personnel that help the user to resolvedrug-related and technical issues. According to another embodiment ofthe invention, Pod 220 has a video output connector that permits thecontent to be displayed on a television screen. The video outputconnector may be wired or a wireless video may be provided, as known.

According to one embodiment of the invention, an LED 230 can also beused to provide visual feed-back to the user. For example, suchfeed-back can be green, if the drug is safe to take or red, if not.

In addition, according to a preferred embodiment of the invention, anoptical or RFID reader 212 can be provided to read barcode or other dataencoded on drug packaging, such as syringes, or other packaging forprescription or non-prescription drugs, vitamins or food supplements.

FIG. 3 is a block diagram illustration of a preferred embodiment for aset-up process. In step 300, the user receives a Pod, such as Pod 220 inFIG. 2, e.g., via mail. Each Pod has a unique ID number, such as MACaddress associated with it, and this ID preferably is associated withthe user account stored in Pod Server 130 in FIG. 1, at the time ofordering. In step 301, the Pod is powered up. At this stage, initialsetup parameters are fed into the Pod. These parameters may includeusername, password, and specify a wireless or other network to connectto, including network access keys, such as WEP (Wireless EncryptionProtocol) or encryption keys or codes, as required by the particularnetwork. Another aspect of this step is to send to the Pod, via thenetwork, the current time and date. It is preferable that, via the IProuting tables, the Pod Server will recognize the time zone the user isin for appropriate time and date information. However, this function mayalso be achieved utilizing alternatives, such as reception of radiowaves, manual time setting, internal clock, satellite signal, GlobalPositioning Technology (GPS), and the like. The time, and possibly thetime zone data, may be used later to alert the user to take medicationson time.

Steps 302, 303 and 304 depict three alternative steps for the entry of auser's drug regimen to the Pod Server. According to a preferredembodiment of the invention, the user can select his preferred optionvia the display 201 in FIG. 2 on the Pod. In step 302, the user willenter his/her regimen by using a PC (Personal Computer) connected to theInternet and, through the Internet, to Web server 140 in FIG. 1.According to another embodiment of the invention, the user may enterhis/her drug regimen via the touch-screen 201 in FIG. 2, by using avirtual keyboard presented on the display.

In step 303, if the user chooses to, the drug regimen can be acquiredand stored as-you-go. In this case, the user starts using the Pod.Initially, no new drug will be verified by the system, and the Pod willalert the user, or his care giver, that the user is taking the wrongdrug. However, while in this mode, the user can override the warning,for example, by typing in his password. By doing this, the userinstructs the system to store and memorize that particular drug as partof his regimen. In addition, the user will input the number of times perday he should take this drug.

In subsequent instances where the user must take the same kind of drugs,no warning will be provided, as the drug is already stored as part ofthe user's regimen. Yet another alternative is depicted in step 304,where the user's drug regimen is acquired from a computerized database.Such databases may exist with the medical insurers or with pharmacychains or can be received from a hospital or doctor's office. Accordingto another embodiment of the invention, the user's drug regimeninformation can be acquired from specific databases, also known asElectronic Medical Records (EMR) or Personal Medical Records (PMR).

In step 305, the Pod server performs an initial drug to drug interactionanalysis, in order to make sure there are no current conflicts betweendrugs taken by a patient. Step 305 may take place following either step302 or 304, or, if step 303 was chosen for the introduction of the drugregimen, it may take place prior to 303 or after 303, as the userchooses. If desired, there can be a link to external databases toprovide such analysis, although preferably such information is stored inthe Pod server. In addition, some safety checks can be made to make surethe dosage is according to manufacturer's recommendations. In step 306the user enters, via elements described in steps 302 or via the website, details of care givers with whom the Pod Server can communicate incase an alert needs to be sent, and communication details forcommunication with these care givers, such as cell phone call, SMS (textmessage), email, instant message and the like. Step 306 can take placeat any time, and is presented here in this order according to apreferred embodiment of the invention.

According to one embodiment of the invention, the system utilizes Podsthat are able to take images or other data regarding drugs and transmitthe information to the Pod server. In preferred embodiments, the Podssend images. It should be noted that images can be acquired usingvarious illumination and imaging sensors, including in wavelengths thatare not visible to the human eye. According to another embodiment of theinvention, the Pods may send a description of images. In anotherembodiment, they send non-image or additional information about drugs,such as bar code or RFID code.

In an embodiment of the invention where a cell phone is utilized as aPod, the user uses the cell phone to take a picture or pictures of apill or pills. Then, using special software that is loaded onto the cellphone, or using the cell phone's capability of sending images to anemail address, sends the image or images to a Pod server. The Pod serveranalyses the images and sends the drug identification and other relevantinformation to the cell phone in the form of a text message or a messageover IP.

In another embodiment of the invention, a purpose-specific Pod isdescribed. The user passes a drug through the Pod. The Pod takes thedrug information as described and, over a communication link, transfersthe information to the Pod server. The Pod server analyses theinformation and transmits feedback to the Pod.

FIG. 4 shows a flow chart that, according to a preferred embodiment ofthe invention, is utilized each time the user takes a drug. In step 401,the user initiates the Pod for the process of analyzing drugs byselecting the “pill taking” menu on the device. According to anotherembodiment of the invention, the Pod is always on, and can automaticallysense the presence of a drug, as by sampling one camera several timesper second, or by using a drug entry sensor (not shown), various typesof which exist commercially. One example of such a sensor is an IR(Infra Red) sensor.

As an alternative, in step 402, the Pod, knowing the time the usershould take each drug, initiates an alert to the user, reminding him/herof the time and the exact drug that should be taken.

In step 403, the user slips in the drug through the entry opening (203in FIG. 2), or reads bar code of a syringe or other drug packaging.

Step 420 is image acquisition and processing, wherein various images ofthe pill or the bar code or other identification element are acquired.The outcome of step 420 is a series of segmented raw images, asexplained in detailed in Applicants' co-pending application cited above.The Pod now verifies that it has connectivity to the Pod Server, step405. If it is not connected, the raw images are stored on the Pod, step406, and will be fed to the Pod Server at a later time. Optionally,according to another embodiment of the invention, the Pod can performimage comparisons to previously stored images or extract some featuresout of the raw images in an attempt to verify there is no unexpecteddrug taken, even before the complete analysis is carried out.

This serves to expedite the transmission process by avoiding sendingbackground image data, thus reducing the quantity of data transmitted.In step 430, image processing and analysis takes place. According to apreferred embodiment of the invention, this takes place on the PodServer. However, according to another embodiment of the invention,processing can be performed in the Pod itself or on an attached PC or asimilar computing device. At this stage, drug identification isperformed and the result is transmitted back to the Pod.

If the drug was not identified, step 408, a warning signal is deliveredby the Pod, step 411, by using visual signals (for example a yellowlight) or audible signals, and possibly accompanied by a suitabledisplay that suggests the user to either try passing the drug once againthrough the Pod, or contact customer support. Then the user can proceedto the next drug, step 415.

If the drug was positively identified, step 408, the name, and possiblydosage, of the drug is displayed on the Pod, step 409. According toanother embodiment of the invention, the Pod can use digital voicecapabilities to vocalize the name, dosage and, if desired, other advice.The Pod Server now performs in-depth analysis for drug-drug interaction,step 410, compliance with the drug regimen for that user in accordancewith the user's clinical information, recommendations for morecost-effective generic alternatives for subsequent purchases, andsimilar data.

This detailed analysis is performed on the Pod server, according to apreferred embodiment of this invention; however it should be noted thatthe analysis can be performed on the Pod itself, or on an attachedcomputing device, such as a PC. The in-depth analysis is done bycomparing the pills the particular patient, or user is about to take,with a pre-stored drug regimen for that person, plus comparing what thatpatient has taken previously to known drug-drug interactions. Thesepotentially harmful interactions can be found in commercially availabledrug data-bases and are updated on a regular basis by health authoritiesin each country, for example, the FDA in the USA.

The severity of the results is then evaluated, step 412. If the severityis high—for example, a wrong drug was detected or a potential drug-druginteraction was detected, an alarm signal is provided, step 414. Thisalarm signal can be any combination of light, text display or audiblealarm, or any other suitable alarm. According to a preferred embodimentof the invention, a suitable text is displayed on the display of thePod, explaining the meaning of the alarm. According to anotherembodiment of the invention, the Pod will not let the drug go through,by not releasing revolving gate 208 in FIG. 2, or blocking the releaseof the drug or drugs if the entry/exit mechanism is different. The drug,in this case, will be released only by a conscious action of the user,such as pressing a special button or selecting a special menu option.The situation described in step 414 can be resolved by either the userinput, which acknowledges the error status as described, or, accordingto another embodiment of the invention, by contacting a support centerthat can release the drug by issuing a command remotely via the PodServer. The user then can decide whether he/she should take the drugregardless, or contact a physician or pharmacist for further advice.

Once processing of a drug is completed, the Pod is ready to process thenext drug, step 416. If there are no more drugs to take, the Pod resetsitself back to the initial state, either automatically, for example, ifit does not sense activity within a pre-determined timeout, such as 5minutes, or, according to another embodiment of the invention, waits fora reset button or a start button to be pressed to go to the initialstate.

If the drug is found to be safe, a safe indication light is lit, step413, and the controller lets the drug exit the Pod, as by commandingmotor 209 in FIG. 2 to revolve gate 208 in FIG. 2, effectively allowingthe drug to roll out through drug exit 211 in FIG. 2. The user will takethe drug or drugs, and move on to the next drug or to an initial state,as described.

FIG. 5 is an example of a web page of an interactive web service,according to one embodiment of the invention. This screen will bepresented when a user, using any web-enabled device, such as a PC orcellular phone, accesses the web server. According to another embodimentof the invention, this screen can be presented on the Pod display forenabling similar capabilities. If such an implementation is chosen, thePod will need a keyboard connected to it via an appropriate interface,such as USB, or a touch-screen display or a similar input unit, forproviding the user's input to the Pod.

Item 501 is a welcome message, possibly accompanied by some securitymeasures to enhance the security of the site. In items 502 and 503, theuser is requested to input his or her unique username and password, asis known in Internet practice. In item 504, according to a preferredembodiment of the invention, there is a field for entering a code thatis presented on the Pod screen. This code is sent to the Pod by the PodServer when the user enters the screen or web page 500, as follows. Theweb browser sends the Web Server the user name that is stored on the PC,typically as a cookie, or using similar known Internet practice.Following that, the Web Server instructs the Pod Server to send aunique, randomly selected code to be displayed on the Pod screen. Theuser should copy this code into the web site interface 500, in field504. This creates another layer of security and enhances the overallsafety of the system described herein.

If the user does not have a user name yet, he or she must select field505. The user will be asked for details for authentication in order tocreate an account. According to a preferred embodiment of the invention,the user's account will be generated automatically when the user ordersa Pod. According to yet another embodiment of the invention, the Pod maybe sold in a retail store or on a retail web site, and the account willbe generated on-line after the Pod is delivered, as by clicking on field505, as described.

FIG. 6 presents a personal file web display 600, according to apreferred embodiment of the invention. This screen is presented to theuser after the user has logged in to the Web server, as described inFIG. 5. A column headed by column header 603 shows the drugs that are onfile in the Pod for this user. According to a preferred embodiment ofthe invention, the user can click on each entry in this column anddisplay additional information about the drug. Such information mayinclude a picture of the pill, or a barcode for a syringe, explanationabout the activity of the drug, indications, contra-indications, knowndrug-drug interactions with other medications or with food or with foodadditives, how the drug should be used, normal dosage range, what to doin case of excess dose, common side effects, history of drug taking,compliance graph, and the like. According to one embodiment of theinvention, a banner 607 is displayed to encourage users to read thisadditional information.

Column 602 presents, for each drug, the dose this user must take. Thisinformation, like all the other information on this page, is preferablytaken from a database that is maintained and updated on an on-goingbasis by the Pod server and, in some cases, by the Web server. Column601 shows the frequency of taking this drug, for example, three pillsper day.

Column 604 displays the last time this drug was taken by the user. Sincethe Pod provides feedback to the Pod server each time any drug is taken,the Pod server maintains detailed consumption records in a database, andthis information can be retrieved by the Web server for display andreview, both by the user, as shown in this figure, and also by a caregiver or the pharmaceutical company that produces the drug, for followup and research purposes. Known security and privacy measures need to betaken to ensure that only authorized people or entities will be able toaccess this data. According to one embodiment of the invention the usercan click on this data field and view his consumption history. Banner608 can direct the user to do so, but other known user interface graphicelements, such as a bubble that pops up when the pointer is over thedata field or other known Internet interface methods, can be appliedhere.

Field 605 shows the time to take the next dose. As the drug regimen isstored in the database maintained by Pod server, the system canautomatically calculate the time for the next dose of that particulardrug. By clicking on this data field, the user can override the nextpre-set time, and modify alert techniques which the system will use tonotify both the user and, optionally, a care giver if this drug was nottaken on or around the predicted time.

In column 606, there are particular comments about the medication.According to one embodiment of the invention, the user can click on anitem in this list to modify or personalize the comment. According toanother embodiment of the invention, the comment will be displayed onthe Pod at the time it identifies this particular medication, to remindthe user about special precautions or instructions for this particularmedication.

A button 610 is provided in this screen, according to a preferredembodiment of the invention, in order to enable the user to temporarilyblock all alerts. This is useful when, for example, the user is planningto go on a trip and may not be able to use the Pod for hours or days. Ifthe user selected this option, the writing on this button is changed to“enable” so the user, upon returning, will be able to re-enable thealert function. Known error processing techniques, such as a time outafter which alerts will be re-enabled, scheduled re-enablement, orautomatic re-enablement the next time the user logs in can also beimplemented.

According to another embodiment, additional information, such as helplines 607 or 609, may exist on the page, as well as additional elements,such as advertisements or promotional information, as is customary onweb pages.

FIG. 7 depicts another embodiment of the invention. According to thisembodiment, a Pod 701 contains only minimal electronics, which may bringits manufacturing cost down. Instead, or in addition, Pod 701 isconnected to a personal computer (PC) 702 via any suitable link 706.According to one embodiment of the invention, this link may be eitherUSB or wireless Bluetooth. A possible benefit of the link to a PC is toeliminate the need for power, as power can be provided over the USBcable. PC 702 must run appropriate software that communicates both withPod 701 and with Pod Server 704 via a communication network 703. Suchcommunication network may be the Internet. The functions of the PCsoftware may be similar to those described for the Pod Server. The PC isalso connected via the Internet or a communication network 703 to a webserver 705.

It is a particular feature of the invention that the system utilizessubstantially direct evidence of drug taking, rather than indirectevidence, as in the prior art. According to the invention, the Podexamines the actual pill, immediately prior to its consumption and, fromthat information, the system determines which drug is taken. Prior artsolutions monitor when a pill container has been opened, but cannot tellif zero, one, or more pills were actually taken out.

While the invention has been described with respect to a limited numberof embodiments, it will be appreciated that many variations,modifications and other applications of the invention may be made. Itwill further be appreciated that the invention is not limited to whathas been described hereinabove merely by way of example. Rather, theinvention is limited solely by the claims which follow.

1. A system for managing a prescribed drug regimen for a user, thesystem comprising: at least one electronic device (Pod) for interactivecommunication with at least one user; wherein each said Pod includes: atleast one sensor for sensing and recording at least one visualcharacteristic of a pill to be taken by one of said users, wherein thevisual characteristic of the pill is selected from at least one of thegroup consisting of size, color, markings, and images analyzed ininfra-red light; means for transferring recorded characteristics to aPod server for analysis of compatibility of said pill with apre-selected drug regimen; means for registering said Pod with the Podserver as belonging to the user; means for receiving from said Podserver analyzed data regarding compatibility; and a display fordisplaying said received data; wherein said Pod server is coupled via acommunication link to each said at least one Pod, said Pod servercomprising an analysis unit, said analysis unit including: a drugcharacteristics database, and a drug interactions database or a link toan external database having such information; and a processor forreceiving said output signals, and for comparing sensed characteristicsof said pill in the at least one said Pod with visual characteristics ofa plurality of drugs in said drug characteristics database, wherein thedrug characteristics database comprises visual characteristics of theplurality of drugs, the characteristics of the plurality of drugsselected from the group consisting of size, color, markings, and imagesanalyzed in infra-red light, so as to identify said pill, and to provideto said Pod an indication of compatibility of said pill with the drugregimen.
 2. The system according to claim 1, wherein: said sensorcomprises means for capturing images of said visual characteristic ofsaid pill to be taken; and said drug characteristics database includesimages of the plurality of drugs that are pills; and wherein saidprocessor is adapted for comparing said captured images with said imagesin said drug characteristics database so as to identify said pill andindicate to the Pod compatibility of the pill to the drug regimen. 3.The system according to claim 2, wherein: each said Pod furthercomprises a user interface including: means for entry of a user' s drugregimen to said Pod; and said means for transferring is adapted totransfer said entered drug regimen to said Pod server.
 4. The systemaccording to claim 1, wherein said processor includes means forproviding an indication of potential drug interactions for display onsaid display.
 5. The system according to claim 2, further comprising auser's web interface including a personal file web display displayingsaid user's drug regimen.
 6. The system according to claim 5, whereinsaid personal file web display includes: a list of pills on file in thePod for a user according to a drug regimen; dosage and frequency foreach pill; and compliance data.
 7. The system according to claim 1,further comprising at least one external sensor, coupled to said Pod,for measuring a physiological parameter of the user that is controlledby at least one drug in the drug regimen.
 8. The system according toclaim 1, further comprising a personal computer (PC) coupled to said Podand, via said communication link, to said Pod server, wherein: said Podincludes said at least one sensor and means for providing an outputsignal corresponding to said sensed characteristics; and said PCcomprises said means for transferring; said means for receiving;software for communicating both with said Pod and with said Pod Servervia communication links; and said display.
 9. The system according toclaim 1, further comprising a pill dispenser coupled to said Pod fordispensing a pill into said Pod for identification.
 10. The systemaccording to claim 1, wherein said Pod is a cellular telephone.
 11. Thesystem according to claim 1, wherein said Pod further comprises adatabase of drug interactions; and wherein said processor includes meansfor providing an indication of potential drug interactions for displayon said display.
 12. A method for monitoring a drug regimen, the methodcomprising: sensing and recording selected visual characteristics of apill to be identified in at least one electronic device (Pod) forinteractive communication with at least one user, wherein said visualcharacteristics of the pill are selected from at least one of the groupconsisting of size, color, markings, and images analyzed in infra-redlight; transferring said recorded characteristics to a Pod servercoupled via a communication link to each said at least one Pod, said Podserver comprising an analysis unit, said analysis unit including adatabase of drug characteristics of a plurality of drugs and a processorfor analysis for compatibility with a pre-selected drug regimen, whereinthe database comprises visual characteristics of the plurality of drugs,the visual characteristics of the plurality of drugs selected from thegroup consisting of size, color, markings, and images analyzed ininfra-red light; registering said Pod with said Pod server as belongingto said user; comparing in said processor sensed characteristics of apill in one of said Pods with characteristics in said drugcharacteristics database, so as to identify said pill; said processorproviding to said Pod an indication of compatibility of said pill withthe drug regimen; said Pod receiving analyzed data of said recordedcharacteristics regarding compatibility; and said Pod displaying saidreceived data.
 13. The method according to claim 12, further comprisingbased on said identification, either releasing said pill to said user orblocking said pill inside said Pod.
 14. The method according to claim12, further comprising providing a drug interaction database in saidserver; and determining, in said processor, if adverse drug interactionsexist with said pill; and providing an alert in pre-defined situations.15. A method for managing a prescribed drug regimen for a user, themethod comprising: providing a user with an electronic device (a Pod)for interactive communication with said user, said Pod having a uniqueidentifier, and providing a server, coupled via a communication link tosaid Pod, said server including a database of drug characteristics of aplurality of known drugs, and a processor; registering said Pod withsaid Pod server as belonging to said user; entering a drug regimen ofthe user into the Pod; receiving a pill in said Pod for identification;sensing selected characteristics of said pill in said Pod andtransmitting sensed characteristics to said server, wherein said sensedcharacteristics are selected from at least one of the group consistingof size, color, markings, and images analyzed in infra-red light;comparing, in said processor, said sensed characteristics withcharacteristics of the plurality of known drugs, wherein comparedcharacteristics are selected from the group consisting of size, color,markings, and images analyzed in infra-red light; and said processorproviding an identification of said pill to said Pod when a match isfound.
 16. The method according to claim 15, further comprising the stepof displaying a notification when said pill is compatible with said drugregimen and releasing said drug from the Pod.
 17. The method accordingto claim 15, further comprising performing a drug interaction analysisand providing an indication of compatibility between said pill and drugsin said drug regimen for display on said display.
 18. The methodaccording to claim 17, further comprising providing an alert when saidpill is not compatible.